CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled

Medical Components is recalling 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, distributed nationwide in the US. The recall was initiated on 13 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730

Quantity recalled6830

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2217-2019
FDA event ID: 83324
Recalling firm: Medical Components, Harleysville, PA
Classification: Class II
Status: Terminated
Recall initiated: 13 Mar 2019
FDA classified: 7 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

13 Mar 2019	Recall initiated by company
7 Aug 2019	Classified by FDA	+147 days
14 Aug 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter

Where it was distributed

US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

Nationwide California Florida Georgia Kentucky Louisiana Massachusetts Michigan Missouri Mississippi New Jersey New York Pennsylvania South Carolina Tennessee Texas Virginia West Virginia

Questions about this recall

Is 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled?

Yes. Medical Components recalled 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits on 13 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-2217-2019.

Why was it recalled?

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Which lots are affected?

MCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730

Where was it sold?

US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medical Components

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Reported	Class	Recall	Company	Reason	Where
17 Mar 2021Device	CLASS II	Power Injectable CT Port insertion kits recalled by Medical Components	Medical Components	Packaging Defects	Nationwide
16 Sep 2020Device	CLASS II	Medcomp SF Titan HD Catheter (Cuff From Tip) recalled	Medical Components	Packaging Defects	12 states
6 Nov 2019Device	CLASS II	C3 Wave App, v recalled by Medical Components	Medical Components	Device Malfunction	13 states
14 Aug 2019Device	CLASS II	14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled	Medical Components	Packaging Defects	Nationwide
14 Aug 2019Device	CLASS II	14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled	Medical Components	Packaging Defects	Nationwide

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